一项包含呼吸练习、冷暴露和冥想的附加训练计划可减轻中轴型脊柱关节炎的炎症和疾病活动——一项概念验证试验。
An add-on training program involving breathing exercises, cold exposure, and meditation attenuates inflammation and disease activity in axial spondyloarthritis - A proof of concept trial.
机构信息
Department of Orthopaedic Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Department of Rheumatology and Clinical Immunology, Amsterdam UMC, University of Amsterdam, Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands.
出版信息
PLoS One. 2019 Dec 2;14(12):e0225749. doi: 10.1371/journal.pone.0225749. eCollection 2019.
OBJECTIVES
The primary objective of this trial was to assess safety and anti-inflammatory effects of an add-on training program involving breathing exercises, cold exposure, and meditation in patients with axial spondyloarthritis.
METHODS
This study was an open-label, randomised, one-way crossover clinical proof-of-concept trial. Twenty-four patients with moderately active axial spondyloarthritis(ASDAS >2.1) and hs-CRP ≥5mg/L were included and randomised to an intervention (n = 13) and control group (n = 11) group that additionally received the intervention after the control period. The intervention period lasted for 8 weeks. The primary endpoint was safety, secondary endpoints were change in hs-CRP, serum calprotectin levels and ESR over the 8-week period. Exploratory endpoints included disease activity measured by ASDAS-CRP and BASDAI, quality of life (SF-36, EQ-5D, EQ-5D VAS), and hospital anxiety and depression (HADS).
RESULTS
We found no significant differences in adverse events between groups, with one serious adverse event occurring 8 weeks after end of the intervention and judged 'unrelated'. During the 8-week intervention period, there was a significant decline of ESR from (median [interquartile range] to 16 [9-26.5] to 9 [5-23] mm/hr, p = 0.040, whereas no effect was found in the control group (from 14 [8.3-27.3] to 16 [5-37] m/hr, p = 0.406). ASDAS-CRP declined from 3.1 [2.5-3.6] to 2.3 [1.9-3.2] in the intervention group (p = 0.044). A similar trend was observed for serum calprotectin (p = 0.064 in the intervention group versus p = 0.182 in the control group), but not for hs-CRP.
CONCLUSIONS
This proof-of-concept study in axial spondyloarthritis met its primary endpoint with no safety signals during the intervention. There was a significant decrease in ESR levels and ASDAS-CRP upon the add-on training program in the intervention group. These findings warrant full-scale randomised controlled trials of this novel therapeutic approach in patients with inflammatory conditions.
TRIAL REGISTRATION
ClinicalTrials.gov; NCT02744014.
目的
本试验的主要目的是评估呼吸训练、冷暴露和冥想附加训练方案在中轴型脊柱关节炎患者中的安全性和抗炎效果。
方法
这是一项开放标签、随机、单盲交叉临床试验。共纳入 24 例中轴型脊柱关节炎（ASDAS>2.1 且 hs-CRP≥5mg/L）患者，随机分为干预组（n=13）和对照组（n=11），对照组在干预结束后接受附加干预。干预持续 8 周。主要终点为安全性，次要终点为 8 周时 hs-CRP、血清钙卫蛋白和 ESR 的变化。探索性终点包括 ASDAS-CRP 和 BASDAI 评估的疾病活动度、生活质量（SF-36、EQ-5D、EQ-5D VAS）和医院焦虑抑郁量表（HADS）。
结果
两组不良事件无显著差异，干预结束 8 周后发生 1 例严重不良事件，判断为“无关”。在 8 周的干预期间，ESR 显著下降（中位数[四分位间距]：从 16[9-26.5]降至 9[5-23]mm/hr，p=0.040），而对照组无显著变化（从 14[8.3-27.3]降至 16[5-37]mm/hr，p=0.406）。干预组的 ASDAS-CRP 从 3.1[2.5-3.6]降至 2.3[1.9-3.2]（p=0.044），血清钙卫蛋白也呈类似趋势（p=0.064 与 p=0.182），但 hs-CRP 无显著变化。
结论
这项中轴型脊柱关节炎的概念验证研究达到了主要终点，干预期间无安全信号。干预组在附加训练方案后 ESR 水平和 ASDAS-CRP 显著降低。这些发现为炎症性疾病患者采用这种新的治疗方法进行全面的随机对照试验提供了依据。
试验注册
ClinicalTrials.gov；NCT02744014。
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